...
  • 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>The regulatory affairs journal: Pharma >The Regulation of Advanced Therapies: Perspectives from the EUThe new regulation on advanced therapy products has closed a gap in the EU regulatory framework, but how will it serve industry compared with the older system in the US? Wolfgang Rehmann and Gareth Morgan report.
【24h】

The Regulation of Advanced Therapies: Perspectives from the EUThe new regulation on advanced therapy products has closed a gap in the EU regulatory framework, but how will it serve industry compared with the older system in the US? Wolfgang Rehmann and Gareth Morgan report.

机译：先进疗法法规：欧盟的观点先进疗法产品的新法规填补了欧盟法规框架中的空白，但是与美国的旧体系相比，它将如何为行业服务？ Wolfgang Rehmann和Gareth Morgan报告。

获取原文
获取原文并翻译 | 示例
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

This article compares and contrasts the regulatory frameworks in the US and the European Union for so-called "advanced therapies" that are being developed from human blood, cells, skin, bone and tissues. Such therapies are revolutionising the treatment of diseases and injuries, such as cancer, Parkinson's disease, burns and cartilage injuries and regulating them is an important issue for governments.In the US, the regulatory scheme for advanced therapies initially was limited to human blood and basic tissues, such as bone, skin, ligaments, tendons and others intended for homologous use. In 2005, the Food and Drug Administration amended its regulatory framework by adding a number of components dealing with the eligibility of donors of human cells, good tissue practices, testing, labelling and other important requirements for guaranteeing product safety. The FDA not only requires compliance with the relevant standards, which are constantly evolving and set out in guidelines, but also insists that products receive authorisation before their marketing as a drug, biological or medical device. The extensive federal control is based on the FDA's use of Section 361 of the Public Health Service Act on prevention of communicable disease transmissioni and, unlike in the EU, is not based on a new regulatory framework implemented specifically for advanced therapy medicinal products.This new European legal framework - Regulation (EC) No 1394/2007 - was implemented on 30 December 2008 and is applicable for new products coming on to the market2. Prior to the regulation, products derived from genes and cells were mostly classified as pharmaceuticals; tissue-engineered products were not explicitly covered by the existing legal framework and were thus only partly classified as pharmaceuticals or as medical devices. Also, regulations were not harmonised across EU member states.
机译：本文比较并对比了美国和欧盟针对从人体血液，细胞，皮肤，骨骼和组织发展而来的所谓“先进疗法”的监管框架。这些疗法正在彻底改变疾病和伤害的治疗方法，例如癌症，帕金森氏病，烧伤和软骨伤害，对它们的管理是各国政府的重要问题。在美国，先进治疗的监管方案最初仅限于人体血液和基本疗法。组织，例如骨骼，皮肤，韧带，肌腱和其他打算用于同源用途的组织。 2005年，美国食品药品监督管理局（FDA）修改了其监管框架，增加了许多有关人体细胞供体的资格，良好的组织规范，测试，标签以及其他保证产品安全的重要要求的组成部分。 FDA不仅要求遵守相关标准，该标准在不断发展并在准则中有所规定，而且还坚持要求产品在作为药物，生物或医疗设备销售之前获得授权。广泛的联邦管制基于FDA对预防传染病传播的《公共卫生服务法》第361节的使用i，与欧盟不同，它并非基于专门针对先进疗法药物实施的新监管框架。欧洲法律框架-第1394/2007号法规（EC）于2008年12月30日实施，适用于投放市场的新产品2。在监管之前，源自基因和细胞的产品大多被归类为药品。现有法律框架并未明确涵盖组织工程产品，因此仅将其部分分类为药品或医疗器械。此外，欧盟成员国之间的法规也不统一。

著录项

相似文献

  • 外文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号